[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chrohns-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chrohns-disease":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,70],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":25,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100652376","gpx4-expression-after-kono-s-vs-conventional-anastomosis-100652376",false,"NCT07772037","GPX4 Expression After Kono-S vs Conventional Anastomosis","Oxidative Epithelial Injury After Ileocolic Resection a Retrospective Pilot Study Comparing Kono-S Versus Conventional Anastomotic Configurations Using Intestinal Epithelial GPX4 Expression.","Inclusion Criteria:• Adults (≥18 years) with confirmed Crohn's disease who underwent ileocolic or small bowel resection with a primary anastomosis.\n\n* Documented anastomotic configuration (Kono-S or conventional).\n* Availability of archived pathology material from the resection specimen containing the anastomotic site.\n* At least one additional tissue timepoint available: preoperative endoscopic biopsy or follow up endoscopic biopsy within 24 months.\n* Available postoperative endoscopic follow up data (Rutgeerts score) where applicable.\n\nExclusion Criteria:\n\n* • Indeterminate colitis or non-Crohn's pathology on histology.\n\n  * Lack of retrievable tissue or poor tissue quality (e.g., extensive necrosis or autolysis) precluding IHC.\n  * Unclear anastomotic type.\n  * Absence of epithelial component in the available tissue (e.g., only serosa or fibrofatty tissue).\n  * Major confounders that could affect GPX4 expression, such as severe ischaemia, uncontrolled sepsis, or immediate reoperation at the anastomotic site.\n  * Patients with permanent stomas and no anastomotic follow up where interpretation would be ambiguous.","ALL","18 Years",{"count":19,"type":20},25,"ESTIMATED","OBSERVATIONAL","Crohn's disease is a long-term condition that causes inflammation in the bowel. Many people with Crohn's will need surgery at some point to remove damaged sections of intestine. Although surgery can improve symptoms, the disease often comes back near the join (anastomosis) where the bowel has been reconnected.\n\nSurgeons use different techniques to reconnect the bowel. One newer approach, called the Kono-S anastomosis, is designed to reduce the risk of Crohn's disease returning. Early results are promising, but it is still not fully understood why it may work better than traditional methods.\n\nThis project aims to explore how the bowel heals after surgery by looking at oxidative stress, a type of tissue damage caused by an imbalance of harmful molecules in the body. The investigators will focus on a protective protein called glutathione peroxidase-4 (GPX4), an anti-oxidative enzyme that reduces oxidized phospholipids in biomembranes.\n\nBy analysing tissue samples taken before and after surgery, the investigators will compare patients who had the Kono-S technique with those who had standard surgical joins. The investigators want to see whether differences in healing at a microscopic level could explain why some patients do better than others.\n\nThe findings from this study could:\n\n* Improve understanding of why Crohn's disease comes back after surgery.\n* Help surgeons choose the best technique for each patient.\n* Support the development of new treatments aimed at improving healing. Ultimately, this research aims to reduce the risk of disease recurrence and improve long-term outcomes for people living with Crohn's disease.",[24],"Chrohn's Disease",[26,27],"anastomotic healing,","GPX4","NOT_YET_RECRUITING","2026-08-17",{"date":31,"type":32},"2026-08-19","ACTUAL",{"date":34,"type":20},"2026-11",{"date":36,"type":20},"2027-11",{"name":38,"class":39},"East Kent Hospitals University NHS Foundation Trust","OTHER_GOV",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":48,"sex":16,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":53,"conditions":54,"keywords":57,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":4,"leadSponsor":67,"locationsCount":40},"100054259","immune-regulation-in-ulcerative-colitis-or-crohn-s-disease-100054259","NCT00001184","Immune Regulation in Ulcerative Colitis or Crohn s Disease","A Natural History Study of the Immune Regulation of Idiopathic Inflammatory Bowel Diseases: Crohn's Disease, Ulcerative Colitis, and Other Inflammatory Conditions of the Gut","* INCLUSION CRITERIA:\n\n  1. Patients with a verifiable diagnosis of Crohn s disease, ulcerative colitis, or IBD known to be associated with a co-existing condition and which is supported by characteristic clinical features, radiographic or endoscopic findings, or consistent histopathologic mucosal\n\n     changes OR\n  2. Patients with clinical features consistent with an unclassified inflammatory bowel disease and histologic evidence of inflammation of the intestine OR\n  3. Patients with any clinical features consistent with inflammatory bowel disease (intestinal inflammation), including but not limited to abdominal pain, fistulae, weight loss, diarrhea, hematochezia or melena or suggestive extra-intestinal symptoms (pyoderma, erythema\n\n     nodosum, axial and articular arthralgias, uveitis, fatigue, fever), in which a diagnosis has not been verified. OR\n  4. Patients who have a defined genetic syndrome linked to inflammatory bowel disease risk with or without symptoms or findings consistent with IBD\n  5. All subjects to be enrolled will be between ages 0-75 (Participants coming to the NIH Clinical Center must meet age and weight requirements of the clinical center, but \\> 18 must years old for patients without IBD and may be as young as 0-2 years old for mail-in\n\n     samples).\n  6. To participate in the research biopsies during endoscopy, subjects must have the following lab values within two weeks of the procedure:\n\n     * Hematocrit \\> 30%\n     * Platelet count \\> 100,000\n     * PT INR \\\u003C 1.3 or PTT prolonged by \\\u003C 3 seconds\n  7. Ability to consent to the protocol on their own.\n\nINCLUSION CRITERIA FOR HEALTHY VOLUNTEERS:\n\n1. Must be willing to undergo blood draw and\u002For upper endoscopy and colonoscopy with biopsy to obtain material for research purposes.\n2. Must be \\>=18 years old.\n3. Must be willing to submit samples for storage.\n\nINCLUSION OF EMPLOYEES IN THE NIH INTRAMURAL STUDIES:\n\nNIH employees and members of their immediate families may participate in this protocol. We will follow the Guidelines for the Inclusion of Employees in NIH Research Studies and will give each employee a copy of the NIH information sheet on Employee Research Participation.\n\nFor NIH employees:\n\n1. Neither participation nor refusal to participate will have an effect, either beneficial or adverse, on the participant s employment or work situation.\n2. The NIH information sheet regarding NIH employee research participation will be distributed to all potential subjects who are NIH employees.\n3. The employee subject s privacy and confidentiality will be preserved in accordance with NIH Clinical Center and NIAID policies, which define the scope and limitations of the protections.\n4. For NIH employee subjects, consent will be obtained by an individual independent of the employee s team. Those in a supervisory position to any employee and co-workers of the employee will not obtain consent. The protocol study staff will be trained annually on obtaining potentially sensitive and private information from co-workers or subordinates. This training will be reinforced as needed, at weekly team meetings.\n\nEXCLUSION CRITERIA:\n\n1. Failure to meet the inclusion criteria.\n2. Any medical, psychiatric, or social conditions which, in the opinion of the investigators, would make participation in this protocol not in the best interest of the subject.\n\nEXCLUSION CRITERIA FOR HEALTHY VOLUNTEERS:\n\n1. History of inflammatory bowel disease.\n2. Acute systemic or intestinal infection requiring antibiotics\n3. Any condition that, in the investigator s opinion, places the patient at undue risk by participating in the study.",true,"1 Day","75 Years",{"count":52,"type":20},1000,"This study will investigate in patients with Crohn s disease and ulcerative colitis how the body s immune system controls inflammation in the gastrointestinal tract (stomach and intestines)-specifically, how lymphocytes (a type of white blood cell) function in inflammatory responses. This protocol does not involve any experimental treatments.\n\nPatients between the ages of 0 and 75 years of age with Crohn s disease or ulcerative colitis or symptoms of inflammatory bowel disease may be eligible for this study. Screening tests may include the following: medical history and physical examination, routine blood tests, examination of stool specimens, X-rays such as barium enema or upper GI series, proctosigmoidoscopy, colonoscopy, gastroduodenoscopy, and small bowel biopsy.\n\nParticipants will receive medical treatment according to the best generally accepted measures for treating Crohn s disease or ulcerative colitis. This may include anti-inflammatory drugs, immunosuppressive drugs, and antibiotics to treat infections. A surgical consultation may be recommended for patients whose disease does not respond to medical treatment. If surgery to remove intestinal tissue is recommended, a qualified gastrointestinal surgeon will perform the procedure.\n\nIn addition, participants may undergo the following procedures:\n\n* Blood drawing - No more than 450 milliliters (30 tablespoons, or 15 ounces) of blood will be taken from adults over a 6-week period. A maximum of 7 ml (1\u002F2 tablespoon) of blood per kilogram (2.2. pounds) of body weight will be obtained from children within the same time period, with no more than 3 ml\u002Fkg taken at any one time.\n* Leukapheresis - This procedure is done to collect large quantities of white blood cells. Whole blood is collected through a needle in an arm vein, similar to donating blood. The blood is circulated through a machine that separates it into its components, and the white cells are removed. The rest of the blood is returned to the body, either through the same needle or through another needle in the other arm.\n* Intestinal biopsies - Intestinal tissue will be obtained during colonoscopy with intestinal biopsy in patients who require this procedure as part of their standard medical care. Patients are given a sedative to reduce anxiety, but are conscious during the procedure. A flexible tube is inserted into the rectum and large intestine, allowing the physician to see the intestinal mucosa. At various places, small pieces of tissue are plucked out.",[55,56,24],"Inflammatory Bowel Disease","Ulcerative Colitis",[58,59,60],"CGD related IBD","IBD Hermansky-Pudlak Syndrom","Natural History","RECRUITING","2026-08-06",{"date":64,"type":32},"2026-08-07",{"date":66,"type":32},"1998-08-07",{"name":68,"class":69},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":77,"targetDuration":4,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":40},"100641576","phase-4-efficacy-of-top-down-therapy-with-mirikizumab-versus-standard-of-care-with-azathioprine-in-patients-with-newly-diagnosed-moderate-to-severe-crohns-disease-100641576","NCT07659353","Efficacy of Top-down Therapy With Mirikizumab Versus Standard of Care With Azathioprine in Patients With Newly Diagnosed, Moderate-to-severe Crohn's Disease","Efficacy of Top-down Therapy With Mirikizumab Versus Standard of Care With Azathioprine in Patients With Newly Diagnosed, Moderate-to-severe Crohn's Disease: A 52-week, Multicenter, Open-label, Randomized Controlled Trial","Inclusion Criteria:\n\n1. Given written informed consent prior to any study-specific procedures.\n2. Willing and able to complete the scheduled study assessments, including ileocolonoscopy and daily Diary entry.\n3. Willing to comply with contraception requirements (as specified in Section 7.7 Contraception requirements).\n4. Age 18-75 years.\n5. Naïve to thiopurines (azathioprine or 6-mercaptopurine) and methotrexate.\n6. Naïve to advanced therapies (targeted biologic or small-molecule therapies) for Crohn's disease or any other disease.\n7. Early disease: Crohn's disease diagnosed per DGVS\u002FECCO criteria ≤12 months and ≥4 weeks before Week 0 (randomization).\n8. Prior 5-aminosalicylate (5-ASA) and\u002For oral glucocorticoid therapy with inadequate response, loss of response, or intolerance to the agent(s) received.\n9. If receiving systemic GC at screening start: cumulative systemic GC exposure prior to screening start should be ≤8 weeks, and prednisolone ≤20 mg\u002Fday (or equivalent) should be stable for ≥2 weeks before screening colonoscopy.\n10. Oral budesonide must be discontinued ≥2 weeks before screening colonoscopy. A switch to prednisolone is permitted. Oral mesalamine must be discontinued ≥2 weeks before screening colonoscopy.\n11. Evidence of active Crohn's disease at enrollment, defined as all of the following:\n\n    1. CDAI 220-500 at screening and Week 0; and\n    2. CRP \\> ULN and\u002For fecal calprotectin \\>250 μg\u002Fg measured during screening (Week -8 to Week 0); and\n    3. Endoscopic activity on screening ileocolonoscopy (Week -8 to Week 0)\n12. No actively draining fistula at screening and baseline.\n13. No prior CD-related surgery\n\nExclusion Criteria:\n\n1. Acute severe\u002Ffulminant Crohn's disease requiring immediate inpatient management or urgent surgery at screening (e.g., obstructive complication with imminent surgery, perforation, draining fistula, uncontrolled sepsis\u002Fabscess, toxic megacolon).\n2. Oral and rectal 5-ASA or rectal steroids treatment within 2 weeks prior to screening colonoscopy.\n3. History of malignancy, except for non-melanoma skin cancer that has been successfully treated and considered cured at screening.\n4. Planned or foreseeable surgery at or before randomization (Week 0).\n5. Known thiopurine methyltransferase deficiency or known inherited mutated nudix hydrolase 15 (NUDT15) gene.\n6. Known hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption.\n7. Diagnosis inconsistent with Crohn's disease, including ulcerative colitis, indeterminate colitis, microscopic colitis, or other non-CD inflammatory enteropathies.\n8. Clinically important active infection, including but not limited to hepatitis B, hepatitis C, HIV\u002FAIDS, or active tuberculosis (TB).\n9. Detectable hepatitis B virus (HBV) DNA or hepatitis C virus (HCV) RNA at screening.\n10. Latent TB.\n11. Planned receipt of live or live-attenuated vaccines (including Bacillus Calmette-Guerin, BCG) during screening or the study.\n12. Systemic mycoses or parasitosis.\n13. Unstable or uncontrolled illness that could increase risk or confound efficacy assessment, including but not limited to cerebro-cardiovascular, respiratory, gastrointestinal (other than CD), hepatic, renal, endocrine, hematologic, neurological disorders, or active malignancy.\n14. Known systemic hypersensitivity to any study drug or any excipient, or prior acute systemic hypersensitivity to monoclonal antibodies that, in the investigator's judgment, precludes mirikizumab therapy.\n15. Women who are pregnant, lactating or planning pregnancy\n16. Employee of Lilly or any of the organizations involved with this study or study site personnel directly affiliated with this study and\u002For their immediate families.\n17. Participation in another interventional clinical trial involving an investigational product or nonapproved use of a drug within the 12 weeks before screening, or concurrent enrollment in any other clinical study or any other type of medical research judged not to be scientifically or medically compatible with this trial.\n18. Unwilling or unable to comply with eDiary\u002Fdata-capture requirements or other study procedures for the duration of the study.\n19. Committed to an institution by judicial or administrative order.",{"count":78,"type":20},320,"INTERVENTIONAL",[81],"PHASE4","The choice of drug therapy for Crohn's disease depends on several factors, such as the severity of the condition, the sections of the bowel affected, or the patient's previous treatment history. Conventional therapy consists of a short course of corticosteroid treatment followed by azathioprine therapy. Alternatively, there are so-called advanced therapies using biologics (biotechnologically produced protein substances such as antibodies), for example mirikizumab. This study aims to investigate whether direct, early treatment with mirikizumab is more effective than the standard therapy of azathioprine in combination with corticosteroids. Following an inclusion phase, patients will be randomly assigned to either treatment with mirikizumab or azathioprine + corticosteroids. Patients in the azathioprine arm may switch to mirikizumab therapy at three time points from week 24 onwards if they do not respond adequately to azathioprine therapy. The study consists of an initial treatment period of 12 weeks (induction therapy) and a maintenance therapy period of 40 weeks. Patients in the mirikizumab arm receive 13 doses of mirikizumab. This includes initially 900 mg intravenously every 4 weeks followed by 300 mg subcutaneously. In the azathioprine arm patients receive daily administration of azathioprine tablets in combination with a steroid. Assignment to one of the two treatment options is randomised with equal probability for each of the treatment options.",[24],"2026-06-15",{"date":86,"type":32},"2026-06-22",{"date":88,"type":20},"2026-08-01",{"date":90,"type":20},"2029-03-31",{"name":92,"class":93},"University Hospital Schleswig-Holstein","OTHER"]